First clinical trial in USA to test 'liberation treatment'
Posted: Mon Jun 28, 2010 12:05 pm
Researchers at the University at Buffalo are about to launch North America's first clinical trial to test the "liberation treatment," an experimental therapy designed to halt the symptoms of multiple sclerosis.
The landmark prospective, randomized, double-blinded study will test both the safety and efficacy of the endovascular therapy on MS symptoms and progression.
The researchers will examine whether dilating blocked neck veins in MS patients using angioplasty remedies the blockages and improves MS symptoms or progression.
The first leg of the University at Buffalo trial will take two days and will begin Tuesday. Ten patients have already been selected to receive the treatment. They will then be followed for 30 days of analysis to measure the side effects and possible risks of the procedure.
The study will be led by Dr. Adnan Siddiqui and colleagues at the University at Buffalo's Department of Neurosurgery.
Depending on the results, researchers will then embark on Phase 2, which will randomize another 20 MS patients to undergo either angioplasty or a "sham angioplasty" (i.e. a catheter will be inserted but there will be no inflation of the balloon).
Hospital officials say the treatment will be blinded and performed in a way that "neither the patient undergoing the procedure nor the clinicians evaluating the patient will be aware which procedure was performed."
If results suggest the procedure is safe and effective, researchers will apply to study a larger number of patients.
http://ottawa.ctv.ca/servlet/an/local/C ... OttawaHome
The landmark prospective, randomized, double-blinded study will test both the safety and efficacy of the endovascular therapy on MS symptoms and progression.
The researchers will examine whether dilating blocked neck veins in MS patients using angioplasty remedies the blockages and improves MS symptoms or progression.
The first leg of the University at Buffalo trial will take two days and will begin Tuesday. Ten patients have already been selected to receive the treatment. They will then be followed for 30 days of analysis to measure the side effects and possible risks of the procedure.
The study will be led by Dr. Adnan Siddiqui and colleagues at the University at Buffalo's Department of Neurosurgery.
Depending on the results, researchers will then embark on Phase 2, which will randomize another 20 MS patients to undergo either angioplasty or a "sham angioplasty" (i.e. a catheter will be inserted but there will be no inflation of the balloon).
Hospital officials say the treatment will be blinded and performed in a way that "neither the patient undergoing the procedure nor the clinicians evaluating the patient will be aware which procedure was performed."
If results suggest the procedure is safe and effective, researchers will apply to study a larger number of patients.
http://ottawa.ctv.ca/servlet/an/local/C ... OttawaHome